Detailed Action
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Reissue application 19/017,120 filed 01/10/2025 is a Reissue of 17880125 , filed 08/03/2022 ,now U.S. Patent # 11551813, 17880125 is a Continuation of 17406604 , filed 08/19/2021 ,now U.S. Patent # 11437145, 17406604 Claims Priority from Provisional Application 63067774 , filed 08/19/2020.
Terminal Disclaimer
3 The Terminal Disclaimer filed on 11/10/2022 in the prior 17/880,125 application is acknowledged.
Claim Interpretation
4. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
5. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
6. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
Functional Phrase # (FP #)
Claim No.
Functional Phrases that Invoke
§ 112 ¶ 6
Corresponding Structure in the ‘813 Patent
1
1, 3, 7, 8, 11, 15, 19-20, 22,
“an information extraction engine arranged to receive electronic text relating to health of a patient…further arranged to extract said patient diagnostic factors from said electronic text and from said health data of said consumer device or said health device…further arranged to receive…new electronic text indicating that one of said displayed unknown diagnostic factors is now a new patient diagnostic factor that is known or is now a new patient diagnostic factor that is absent and/or that one of said displayed unperformed treatments is now a new performed treatment…further arranged to extract from new electronic text said new patient diagnostic factor and/or new performed treatment.”
Column 7, lines 5-column 10; column 13, lines 4-column 14; columns 21-22; column 27-28.
2
1, 11
“a first trained computer model arranged to extract from said electronic text a plurality of patient diagnostic factors…”
Column 7, lines 5-column 10; column 13, lines 4-column 14; columns 21-22; column 27-28.
3
1, 6, 8, 11, 18, 20, 22
“a condition ranker module arranged to match said patient diagnostic factors in order to produce a list of at least one of said conditions…further arranged to produce an updated condition list based upon said new input…further arranged to produce an updated condition list based upon said new electronic text…
Column 11, lines 22-36; column 14, line 54-column 16, line 40; column 19, lines 9-18;
4
1, 6, 8, 11, 19, 20, 22
“a next-best action engine arranged to determine…a list of unknown diagnostic factors from the set of ranked diagnostic factors…further arranged to determine updated lists of unknown diagnostic factors and/or unperformed treatments based upon said updated condition list…”
Columns 15-16; columns 25-26; figures 10A-10I
5
1, 5, 6, 7, 8, 10, 11, 17-21, 22
“Diagnostic user interface arranged to display on a computer screen said conditions…said diagnostic interface being further arranged to receive…new input…said diagnostic user interface being further arranged to display said updated condition list and said updated lists…displays said conditions of said list, new electronic text...further arranged to display for each condition in said condition list said probability of being present in said patient.. . further arranged to display for each condition in said condition list said probability of being present in said patient.
Figs. 3, 10A, 10B; column 12, line 50-column 13, line 65 ; column 17, lines 40-column 18, line 20.
6
24, 34
One or more processors to: receive sets of ranked diagnostic factors; match said patient diagnostic factors to at least one of said sets of ranked diagnostic factors in order to produce a list of at least one of said conditions…determine…a list of unknown diagnostic factors/unperformed treatments…and output said conditions of said list ordered by the relative weight of being present in said patient along with…said list of unknown diagnostic factors/unperformed treatments.
Column 10, line 24-column 12; column 4, lines 28-column 5, line 30; column 13, line 67-column 16; columns 21-24;
7
28, 40
A user interface is configured to: display said conditions…receive, after said condition of said list is displayed, new input indicating that one of said displayed unknown diagnostic factors/unperformed treatments is now known …
Figs. 3, 10A, 10B; column 12, line 50-column 13, line 65 ; column 17, lines 40-column 18, line 20.
8
29, 41
One or more processors to: produce an updated condition list based upon said new input; determine updated lists of unknown diagnostic factors/unperformed treatements based upon said updated condition list; and output said updated condition list and said updated lists of unknown diagnostic factors/unperformed treatments.
Column 10, line 24-column 12; column 4, lines 28-column 5, line 30; column 13, line 67-column 16; columns 21-24;
9
30, 42
One or more processors to: receive…new data indicating that one of said displayed unknown diagnostic factors /unperformed treatements is now a new patient diagnostic factor/new performed treatement…
Column 10, line 24-column 12; column 4, lines 28-column 5, line 30; column 13, line 67-column 16; columns 21-24;
10
31, 43
One or more processors to: extract said new patient diagnostic factor; produce an updated condition list…determine updated lists of unknown diagnostic factors/unperformed treatments. . . output said updated condition list/unperformed treatments
Column 10, line 24-column 12; column 4, lines 28-column 5, line 30; column 13, line 67-column 16; columns 21-24;
11
32
A natural language processing model configured to receive said electronic text and extract from said electronic text said plurality of patient diagnostic factors
Column 14; figure 2; column 16, lines 60-column 17, line 19;
12
44
A user interface configured to display for each condition in said condition list said relative weight of being present in said patient.
Figs. 3, 10A, 10B; column 12, line 50-column 13, line 65; column 17, lines 40-column 18, line 20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
7. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
8. Claims 1-44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
For Step 1 of the USPTO’s 101 framework, the claims recite a “process, machine, manufacture, or composition” under 101 because the claims recite “a system (i.e. a machine or manufacture).
For Prong 1 of USPTO Step 2A, with the exception of a “user interface” and a “trained computer model” in claims 1 and 11; the “user interface” in claim 22; and the “database” for storing and generic processor in claims 24 and 34, the entirety of the claim can be performed in the human mind. For example, the human mind is capable of receiving an electronic text relating to the health of a patient, extracting diagnostic factors from the electronic text, matching patient diagnostic factors to sets of ranked diagnostic factors to produce a list of at least one condition having a probability of being present in the patient, determining a list of unknown diagnostic factors... that are not known to be present or absent in a patient” and ordering the conditions of a list by a probability of it being present and ordering the list of unknown diagnostic factors by the probability that each indicates a condition. Similarly, the human mind can also determine a list of unperformed treatments and determine an order for the most desirable to least desirable treatments based on probability or weights of those conditions. The claims are recited at a high-level of abstraction and no computer or other tool is needed for those steps. Thus, the claims recite mental processes. Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353-54 (Fed.Cir. 2016) (“we have treated analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category”).
For Prong 2 of USPTO Step 2A, the claims do not integrate the mental processes into a practical application. The limitations drawn to a “user interface” constitutes insignificant post-solution activity analogous to outputting or display the result. The Federal Circuit has explained “merely presenting the results of abstract processes of collecting and analyzing information, without more is abstract as an ancillary part of such collection and analysis.” Elec. Power, 830 F.3d at 1353. Similarly, the “database” performs only its basic function of storing data which is common to all databases. The “trained computer model”, EHR system and generic processor merely integrates the abstract idea on a generic computer. These elements are recited at a high level of generality such that they amount to no more than a mere instruction to apply the exception using generic computer components. As the Supreme Court has said “the mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.” Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 222-23 (2014). Thus, the additional recitations do not integrate the abstract idea into a practical application.
For USPTO Step 2B, the recited “database” and “processor” are generic and high-level. The Specification describes them as well-understood, routine, and conventional computer components. Storing data in a database, without more was well-understood, routine, and conventional and fails to provide significantly more than the abstract idea. The claims do not recite additional elements, when considered individually or in combination, that amount to significantly more than the abstract idea. The reasons for reaching this conclusion are substantially the same as the reasons given above in Step 2A, Prong 2.
Thus, claims 1-44 are directed to an abstract idea without significantly more.
Dependent claims 2-10, 12-21, 23, 25-33, and 35-44 when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed to an abstract idea without significantly more. These claims fail to cure the deficiencies of claims 1, 11, 22, 24, and 34 and are rejected for the same rationale applied to their independent claims from which they depend above.
Allowable Subject Matter
9. Claims 1-44 are allowable over the prior art; however, they remain rejected under 35 U.S.C. 101.
The closest prior art references, Van Assel et al., US 2021/0233658 A1 and Neumann, US 2021/0004714 A1 fall short of disclosing the feature reciting, a diagnostic user interface arranged to display on a computer screen said conditions of said list ordered by the probability of being present in said patient along with, for each condition of said list, said list of unknown diagnostic factors ordered by the probability that each of said unknown diagnostic factors indicates said each condition of said list where the “unknown diagnostic factors” are from the set of ranked diagnostic factors associated with each condition of said list that are not said patient diagnostic factors known to be present or absent in said patient as recited in claim 1 and similarly in claim 22 and 24. Similarly, the references fall short of disclosing the feature reciting, “a diagnostic user interface arranged to display on a computer screen said conditions of said list ordered by the probability of being present in said patient along with, for each condition of said list, said determined list of unperformed treatments ordered from most desirable to least desirable to treat said each condition of said list based upon said ranking for each unperformed treatment where the “list of unperformed treatments” are ranked as recited in claim 11 and “determine, for each condition of said list, a list of unperformed treatments that are not said performed treatments and a ranking for each unperformed treatment of said list of unperformed treatments; and output said conditions of said list ordered by the relative weight of being preset in said patient along with, for each condition of said list, said determined list of unperformed treatments to treat said each condition of said list” as recited in claim 34.
Specifically, Van Assel discloses displaying information regarding the likelihood of a disease and diagnosis on the mobile phone of a user and displaying a list of relevant concepts indicated as present in the clinical history as well as relevant concepts indicated as present or absent for the patient in the clinical history. Van Assel discloses receiving input text information from the interface relating to medical data, risk factors, symptoms, and known diseases of a patient. The diagnostic engine receives the input text information and calls an NLP module that applies NLP techniques to the input text information to extract concepts. Following receipt of an input phrase, the diagnostic engine calls an NLP dependency parser which extracts one or more symptoms which are present in the phrase and outputs the concepts corresponding to the symptoms. Van Assel discloses probabilistic graphical models (PGM) as medical models used to capture the relationship between items of medical data such as risk-factors, diseases and symptoms. Van Assel discloses calculating the probability of certain medical symptoms being related to a particular disease or condition and ranking those conditions based on the input symptoms. Van Assel discloses the evidence such as the symptoms, diseases, risk factors, physiological data, recommendations and/or behaviors, that are identified as present by the patient are passed to a diagnosis engine configured to compute the probabilities that diseases are present based on the evidence and derive a diagnosis from these probabilities. Van Assel discloses that the probabilistic model 112 takes as input evidence, for example the presence or absence of various symptoms, diseases and/or risk factors, from the clinical history and the information received from the user. For symptoms and risk factors where the patient has been unable to provide a response, and for which the status is unknown in the clinical history, or which are not determined to be relevant, these are initially assumed to be unknown. Van Assel further discloses if there is no information in the clinical history regarding the presence or absence of the symptom, or the information in the clinical history is determined to be not valid, the validity module 301 outputs that the presence/absence of the symptom is unknown (0). Van Assel discloses a user interface configured to display a diagnosis based on the probability of the user having a disease. Van Assel discloses if there is no information in the clinical history regarding the presence or absence of the symptom, or the information in the clinical history is determined to be not valid, the validity module 301 outputs that the presence/absence of the symptom is unknown (0). Van Assel discloses the validity module 301 may output the set of IRIs representing the symptoms, risk factors and/or diseases used in the probabilistic model, together with the valid information (for example, the information may indicate, for each concept in the model, whether the concept is validly present, validly absent or whether its presence/absence is unknown). However, while Van Assel discloses displaying a list of unknown diagnostic factors, Van Assel does not disclose the list of unknown diagnostic factors are ordered by the probability that each of said unknown diagnostic factors indicates said each condition of said list. Van Assel discloses simply that the factor is present or absent, but does not disclose ranking or ordering these factors by the probability that each of said unknown diagnostic factors indicates said each condition of said list.
Neumann discloses that the diagnostic factors are ranked based on the probability of the diagnostic factor being indicative of its associated condition. See paragraphs [0079]-[0087] disclosing a machine learning module designed to generate a machine learning model using a machine learning algorithm in which to determine relation between inputs and outputs. A classification device and/or machine-learning module can detect categories of physiological input data and/or relationships of such categories to diagnostic output data using machine learning processes. An initial heuristic can include a ranking of diagnostic output data according to relation to a test type of at least a biological extraction, one or more categories of physiological data, one or more values detected in at least a biological extraction. Ranking includes ranking according to significance scores of associations between elements of physiological input data and diagnostic output data. However, Neuman does not disclose a diagnostic user interface arranged to display on a computer screen said conditions of said list ordered by the probability of being present in said patient along with, for each condition of said list, said list of unknown diagnostic factors ordered by the probability that each of said unknown diagnostic factors indicates said each condition of said list where the “unknown diagnostic factors” are from the set of ranked diagnostic factors associated with each condition of said list that are not said patient diagnostic factors known to be present or absent in said patient.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHNA SINGH DESAI whose telephone number is (571)272-4099. The examiner can normally be reached on M-F 7:30-4PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Kosowski can be reached on 571-272-3744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHNA S DESAI/Primary Examiner, Art Unit 3992
Conferees:
/William H. Wood/Reexamination Specialist, Art Unit 3992
/ALEXANDER J KOSOWSKI/Supervisory Patent Examiner, Art Unit 3992